Biological Process Development Facility (BPDF)

Biological Process Development Facility

The UNL BPDF uses a synergistic, multi-disciplinary approach to advance research-derived candidate vaccines and bio-therapeutics from discovery to Phase I/II clinical trials. For over 13 years, UNL-BPDF has provided customers with access to experienced biopharmaceutical process research and development scientists and engineers, state-of-the-art process development capabilities, and cGMP manufacturing facilities.

The UNL BPDF facility features 6,000 square feet of modular clean rooms and 7,000 square feet of support space, including a pure steam generator, a water-for-injection (WFI) condenser, a 1,000-gallon WFI storage tank, and ambient and hot WFI distribution loops. The cGMP facility has 80 Liter and 200 Liter bioreactors and is able to accommodate a 1000 Liter bioreactor. The BPDF is equipped for downstream processing of both secreted and intracellular products derived from yeast or bacteria and is designed to produce Bulk Drug Substances.

Biological Process Development Facility completes its first cGMP production run in newly commissioned facility

The University of Nebraska-Lincoln Biological Process Development Facility (BPDF) achieved a major milestone by producing its first cGMP batch of bulk drug substance in the recently commissioned facility. At the request of the Mintaka Foundation (Geneva, Switzerland), the BPDF developed and scaled-up a process for cGMP production and purification of 5P12-Rantes, a microbicide effective in preventing transmission of HIV in vitro and SIV in vivo in non-human primate studies. The cGMP product will be shipped to the Mintaka Foundation for formulation as a vaginal cream for use in Phase I clinical trials. Read more.